30 November 2023 | 11am EST / 4pm CET
Laboratory Developed Tests (LDTs) in the U.S. are currently at a pivotal moment. Traditionally, these tests have been under enforcement discretion, but the FDA is now proposing significant regulatory changes.
Over the next five years, the FDA aims to phase out this discretion, introducing a framework that requires comprehensive submissions from LDT providers. This move aligns with the recent EU IVDR implementation, which brought similar oversight to LDTs and all In Vitro Diagnostics (IVDs) in Europe.
Interestingly, the U.S. proposal has already generated substantial feedback, with over a thousand comments submitted, many expressing opposition to the new regulations. This scenario sets the stage for our next RQM+ Live! discussion.
Join us as we delve into critical aspects of this evolving regulatory landscape:
This session promises to be an enlightening exploration of the future of LDT regulation and its impact on the MedTech industry.
Please sign up to join us live by filling out the form.